Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Digoxin

Criteria

Inclusion Criteria:

• Patients with confirmed type 2 diabetes for at least 1 year and treated with metformin as a single treatment or in combination with one other oral anti diabetic for at least 2 months prior to screening.

• Body mass index between ≥19 and ≤42 kg/m2.

• Haemoglobin (Hb) A1c ≥6.5% and ≤9.5% at enrolment.

Exclusion Criteria:

• History of cardiovascular disease, eg, left ventricular hypertrophy, uncontrolled hypertension, paroxysmal or persistent cardiac arrhythmia or ischemic heart disease.

• Systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg at screening

• Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors